Beverage Choice and Lifestyle Modification in Overweight Youth

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT01662570
• Lead Sponsor: University of Pennsylvania

Brief Summary

The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. This research study developed and tested a "Beverage Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. The overall study objectives were to test the acceptability and effectiveness of the BCLM intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and BMI group. The investigators hypothesized that those children randomized to the BCLM group will show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and energy intake than those assigned to our Nutrition Education (NE) group.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2011-11
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-10
• Last Update Submitted: 2012-08-14
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Ages 4-8 years old
• BMI≥85th percentile (based on age and sex)
• consumes large (≥16 oz.day) sugar sweetened beverages

Exclusion Criteria

• Child has a serious medical condition
• Signs of elevated psychopathology are present, as assessed by the Child Behavior Checklist (CBCL)
• Parent demonstrates elevated psychiatric problems or eating disorders
• Failure of parent or child to meet BMI criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	Baseline and Month 6	Change in BMI will be measured from baseline to end of treatment (month 6).
Body Mass Index z-score (BMI-z)	Baseline and month 6	Change in BMI-z will be measured from baseline to end of treatment (month 6).
Body Mass Index Percentile (BMI%)	Baseline and Month 6	Change in BMI% will be measured from baseline to end of treatment (month 6).
Child percent overweight	Baseline and Month 6	Change in child percent overweight will be measured from baseline to end of treatment (month 6).
Waist Circumference	Baseline to Month 6	Change in waist circumference will be measured from baseline to end of treatment (month 6).
Energy (kcal) intake	Baseline to Month 6	Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
Sugar-sweetened beverage intake	Baseline to Month 6	Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
Treatment acceptance and satisfaction	Month 6	Overall treatment acceptance and satisfaction will be measured at end of treatment.

Secondary Outcome Measures

Name	Time	Method
Child preferences and motivation for sugar-sweetened beverages	Baseline and Month 6	Change in child preference and motivation for sugar-sweetened beverages will be measured from baseline to month 6 using a computerized behavioral choice task assessment.

Trial Locations

Locations (1)

University of Pennsylvania Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States